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Phase-Locked Accelerated Intermittent Theta Burst Stimulation for Treatment-Resistant Depression

4. november 2026 oppdatert av: Wei-Chung Mao, Cheng-Hsin General Hospital

Development of Precision Medicine in the Field of iTBS on Patients With TRD Using Multimodal Functional Brain Imaging and Deep Learning

This study aims to investigate whether synchronizing accelerated intermittent theta burst stimulation (aiTBS) with an individual's ongoing brain activity improves treatment outcomes in adults with Treatment-Resistant Depression (TRD).

Participants were randomly assigned to one of two treatment groups:

  1. Phase-locked aiTBS (PL-aiTBS): Magnetic stimulation was synchronized with a specific phase of ongoing brain activity measured using electroencephalography (EEG).
  2. Random-phase aiTBS (RP-aiTBS): Participants received the same stimulation protocol without synchronization to a specific phase of brain activity.

Both groups received personalized stimulation based on their individual theta frequency. Treatment consisted of 10 sessions over three consecutive days, with three sessions on Day 1, three sessions on Day 2, and four sessions on Day 3 (3-3-4 schedule). Each session delivered 1,800 magnetic pulses, resulting in a total of 18,000 pulses per participant.

The primary objective was to compare changes in depressive symptoms between the two treatment groups. Depression severity was assessed using the 17-item Hamilton Depression Rating Scale (HAM-D) and the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline (before the first stimulation session), mid-treatment (after the sixth session, Day 2), post-treatment (after the tenth session, Day 3), and follow-up (Day7).

Resting-state EEG recordings were collected before and after stimulation sessions to investigate treatment-related changes in neural oscillatory activity, phase-amplitude coupling, functional connectivity, and other neurophysiological measures, as well as their potential associations with improvements in depressive symptoms.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

54

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Taipei City
      • Taipei, Taipei City, Taiwan, 112
        • Cheng Hsin General Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 to 70 years.
  • Diagnosis of major depressive disorder (MDD).
  • Inadequate response to at least two antidepressant trials of adequate dose and duration.
  • A 17-item Hamilton Depression Rating Scale (HAM-D) score of 9 or higher.
  • A Montgomery-Åsberg Depression Rating Scale (MADRS) score of 16 or higher.
  • Willingness to participate in the study and provision of written informed consent.

Exclusion Criteria:

  • Other psychiatric disorders or serious medical conditions.
  • Psychotic disorders.
  • Current illicit drug use or alcohol use disorder.
  • Neurological or seizure disorders.
  • Contraindications to transcranial magnetic stimulation (TMS), including cardiac pacemakers or metallic implants.
  • Pregnancy or postpartum depression.
  • Electroconvulsive therapy (ECT) within the previous 12 months.
  • Unstable medical illness.
  • Inability to comply with study procedures.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Phase-Locked Accelerated iTBS (PL-aiTBS)

Participants received individualized accelerated intermittent theta burst stimulation (aiTBS) synchronized to a specific phase of ongoing frontal theta oscillations measured using EEG.

Stimulation was delivered to the left dorsolateral prefrontal cortex (DLPFC; F3) using an individualized theta-frequency-based iTBS protocol. Each participant received 10 sessions over three consecutive days (3-3-4 schedule), with 1,800 pulses per session (18,000 pulses total). Stimulation was synchronized to the trough of ongoing frontal theta oscillations using real-time EEG phase estimation.

Aktiv komparator: Random-Phase Accelerated iTBS (RP-aiTBS)

Participants received the same individualized aiTBS protocol without phase-locked synchronization to ongoing frontal theta oscillations.

Participants received the same individualized iTBS protocol targeting the left DLPFC (F3), consisting of 10 sessions over three consecutive days (3-3-4 schedule), with 1,800 pulses per session (18,000 pulses total). Stimulation was delivered without phase-locked synchronization to ongoing frontal theta oscillations.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in HAM-D Total Score
Tidsramme: Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

Depression severity was assessed using the 17-item Hamilton Depression Rating Scale (HAM-D), with total scores ranging from 0 to 52. Higher scores indicate greater depressive symptom severity. Changes in total scores from baseline were evaluated at each post-baseline assessment.

Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
Change in MADRS Total Score
Tidsramme: Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

Depression severity was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), with total scores ranging from 0 to 60. Higher scores indicate greater depressive symptom severity. Changes in total scores from baseline were evaluated at each post-baseline assessment.

Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Response Rate Based on HAM-D
Tidsramme: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

Treatment response was defined as a reduction of at least 50% in HAM-D total score relative to baseline. The response rate was calculated as the percentage of participants meeting this criterion at each assessment time point.

Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
Response Rate Based on MADRS
Tidsramme: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

Treatment response was defined as a reduction of at least 50% in MADRS total score relative to baseline. The response rate was calculated as the percentage of participants meeting this criterion at each assessment time point.

Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
Remission Rate Based on HAM-D17
Tidsramme: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

Remission was defined as a HAM-D17 total score of 7 or lower. The remission rate was calculated as the percentage of participants meeting this criterion at each assessment time point.

Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
Remission Rate Based on MADRS
Tidsramme: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

Remission was defined as a MADRS total score of 10 or lower. The remission rate was calculated as the percentage of participants meeting this criterion at each assessment time point.

Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Resting-State EEG Spectral Power
Tidsramme: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).

Resting-state electroencephalography (EEG) was recorded to assess changes in neural oscillatory activity following accelerated intermittent theta burst stimulation (aiTBS). Spectral power was quantified across conventional frequency bands, including delta, theta, alpha, beta, and gamma. Changes in spectral power from baseline were evaluated across treatment stages.

Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
Change From Baseline in Resting-State EEG Phase-Amplitude Coupling
Tidsramme: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).

Resting-state EEG was analyzed to assess phase-amplitude coupling (PAC), reflecting the relationship between the phase of lower-frequency oscillations and the amplitude of higher-frequency activity. Changes in PAC strength from baseline were evaluated across treatment stages to characterize neurophysiological effects of aiTBS.

Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
Resting-State EEG Functional Connectivity
Tidsramme: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).

Resting-state EEG functional connectivity was assessed using phase-based synchronization measures between brain regions. Changes in functional connectivity from baseline were evaluated across treatment stages to investigate stimulation-related alterations in neural synchronization.

Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
Change From Baseline in Resting-State EEG Microstate Parameters
Tidsramme: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).

Resting-state EEG microstate analysis was used to characterize changes in the temporal dynamics of large-scale brain network activity. Microstate parameters included mean duration (ms), occurrence rate (events/s), time coverage (%), and transition probabilities between microstate classes. Changes in these parameters were evaluated across treatment sessions to investigate stimulation-related alterations in brain network dynamics.

Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).

Samarbeidspartnere og etterforskere

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. mai 2024

Primær fullføring (Faktiske)

15. april 2026

Studiet fullført (Faktiske)

15. april 2026

Datoer for studieregistrering

Først innsendt

4. november 2026

Først innsendt som oppfylte QC-kriteriene

4. november 2026

Først lagt ut (Faktiske)

10. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

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NEI

IPD-planbeskrivelse

Individual participant data will not be shared publicly due to participant confidentiality and privacy considerations. No external IPD sharing is currently planned.

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Nei

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Nei

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